BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    AdheResp Smart Breath-actuated Mesh Nebulizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464091355·SONIC ENCHANT SE 10 B 105 DG

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209094·NEEDLE HDER CLOSED SELF RIGHTING

    Aequalis PerFORM+ Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODEL 250 SERIES MATERNAL/FETAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALLTHREAD PEEK ANCHOR

    FDA Adverse Event
    Malfunction ·BIOMET SPORTS MEDICINE, INC.·Product code HWC·December 5, 2008

    UNKNOWN DEPUY SZ 3 10MM TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JWH·September 16, 2011

    FLEXICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·July 26, 2013

    TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG

    FDA Adverse Event
    Injury ·TORNIER INC·Product code KWS·March 8, 2024

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013